Orion Pharma's Research and Development is looking for a Regulatory Affairs Specialist to support EU and global regulatory activities for our oncology and pain development-stage pharmaceutical programs.
In this role, you will work under the guidance of senior regulatory professionals to prepare and manage regulatory submissions and contribute to cross-functional project teams within R&D. This is an excellent opportunity for a junior-to-mid level regulatory professional to deepen hands-on experience in clinical development and regulatory submissions. You will be part of a global team with colleagues based in the US, UK, and Finland.
Key Responsibilities:
- Regulatory Submissions: Support the preparation, compilation, and maintenance of regulatory submission packages (e.g. Clinical Trial Applications (CTAs) via CTIS, INDs, amendments, annual reports, briefing documents). Coordinate eCTD publishing and document lifecycle management in collaboration with Regulatory Operations or external vendors. Perform quality control checks to ensure submission documents are complete, accurate, and compliant.
- Regulatory Strategy Support: Execute regulatory strategy tasks as defined by senior team members (Regional Regulatory Leads/Global Regulatory Leads). Gather regulatory intelligence to support development decisions. Track regulatory commitments, key milestones, and health authority feedback for ongoing projects.
- Cross-Functional Collaboration: Collaborate closely with Clinical Development, Clinical Operations, Nonclinical Development, Medical Writing, CMC, and external partners to gather necessary data and documents for submissions. Assist in coordinating internal review cycles, consolidating feedback, and ensuring timely approvals of documents. Actively participate in relevant meetings and document key decisions and action items.
- Health Authority Interactions: Assist in preparing for health authority meetings and correspondence, primarily with European authorities (EMA) and FDA. Support the team in developing meeting briefing packages, rehearsing meeting content, and documenting outcomes and follow-up actions from agency interactions.
- Operational & Process Excellence: Maintain internal regulatory trackers, timelines, and submission plans to ensure on-time execution. Support inspection readiness activities and proper archiving of regulatory documents. Contribute to continuous improvement of internal processes, templates, and best practices within the regulatory affairs function.
This role can be based in our R&D locations within UK or Finland.
What We Offer:
- Impactful Work: An opportunity to be part of a mission-driven organization where your contributions in regulatory affairs help advance new treatments for patients and society.
- Collaborative Culture: A supportive, inclusive work environment rooted in Nordic values of trust, openness, and collaboration. We value each team member's input and foster continuous learning and development. We provide continuous support and comprehensive onboarding to help you develop your capabilities and succeed as part of the team.
- Growth & Development: Opportunities for professional growth, mentoring from experienced regulatory leaders, and exposure to innovative oncology and pain therapy area R&D projects in a global setting.
- Competitive Compensation: A competitive salary and benefits package aligned with your experience and local market standards, plus flexible/hybrid working arrangements.
At Orion Pharma, your work creates true impact and well-being for our customers, patients and society at large. Our culture of friendliness, respect, mutual appreciation and diversity creates a safe working environment where you can strive for excellence. We offer a wealth of career paths and development opportunities that support the development of innovative solutions and improving the quality of life.
Please visit our website to find further information about our values and Orion as an employer https://www.orion.fi/en/careers/orion-as-an-employer/.
Our expectations
- Education: Bachelor's or Master's degree in life sciences, pharmacy, or a related field
- Experience: Approximately 2+ years of Regulatory Affairs experience in the pharmaceutical or biotechnology industry (clinical development stage focus / CRO preferred). Experience supporting oncology or other complex therapeutic area development programs is preferred.
- Regulatory Knowledge: Basic understanding of European regulatory frameworks for drug development (e.g. CTA process and CTIS) and familiarity with global requirements (such as US IND process). Experience in preparing or supporting regulatory submissions or documentation is required. Exposure to eCTD structure and electronic publishing workflows. Experience using regulatory document management systems or submission tracking tools. Prior experience working with CROs or external regulatory vendors.
- Skills: Strong attention to detail, excellent organizational abilities, and the capacity to manage multiple tasks in parallel under tight timelines. Clear written and verbal communication skills in English are essential. Ability to work effectively in cross-functional teams and adapt in a dynamic, fast-paced environment. A proactive, quality-driven mindset with eagerness to learn and adopt regulatory best practices.
How to Apply:
Please submit your application (CV and cover letter in English) by 14th June 2026.
We look forward to learning more about you and how you can contribute to our team!
#LI-ORION
Orion Pharma's pharmaceutical innovations are created within its R&D organization. We employ around 400 top professionals in the field of drug discovery and development. We work globally: in Espoo and Turku in Finland, in Cambridge and Nottingham in England and in Cambridge, MA, USA. Orion R&D and the Innovative Medicines business division are dedicated to making a transformation to become a global player in the pain and oncology therapy areas.
About Us
Orion Pharma is a globally operating Nordic pharmaceutical company - a builder of well-being for over a hundred years.
We're home to more than 4,000 Orionees around the world, and we're proud to be known as a responsible employer and a great place to work. At Orion Pharma, people are truly valued and trusted, encouraged to grow, and supported by a culture where every voice is heard. We appreciate each other, strive for excellence, and build the future.
Together we develop, manufacture, and market human and veterinary pharmaceuticals and active pharmaceutical ingredients. Our extensive portfolio includes proprietary and generic medicines as well as consumer health products. The core therapy areas of our pharmaceutical R&D are oncology and pain. Proprietary products developed by Orion Pharma are used to treat cancer, neurological diseases, respiratory diseases, and more.
We offer careers with a clear purpose: empowering people to live their lives to the fullest.
About Orion
